Actively Recruiting
An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children
Led by University Children's Hospital, Zurich · Updated on 2024-12-11
40
Participants Needed
3
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to find out if using the BougieCap device is a safe and effective way to stretch narrow areas in the esophagus (food pipe) in children. The main questions this study wants to answer are: * Does the BougieCap work well to treat narrow areas in the esophagus comparing with other methods to widen these narrow areas? * Is BougieCap easy to use and does it cause fewer problems or discomfort for children? Researchers will compare two groups: one using the BougieCap, and the other using traditional methods like balloon dilation, to see which one works better and is safer. Participants will: * Answer questions about their symptoms before treatment, 24 hours after, and 14 days later. * Complete these questions during regular hospital visits or over the phone for the final check-up. This study does not involve any extra risks or burdens for the participants.
CONDITIONS
Official Title
An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under 18 years of age
- Indicated for endoscopic esophageal dilation
- Diagnosed with a benign esophageal stricture
- Written informed consent signed by the subject and/or parent or legal representative
You will not qualify if you...
- Esophageal strictures that cannot be treated endoscopically
- Malignant (cancerous) esophageal strictures
- Contraindications or limitations described in the medical device instructions for use
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Maternal and Child Health Department, University Hospital - Umberto I Sapienza - University of Rome,
Rome, Italy, 00161
Actively Recruiting
2
University Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8032
Actively Recruiting
3
Universitäts-Kinderspital beider Basel
Basel, Switzerland, 4056
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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